A Phase III, Double-blind, Randomized, Parallel Group, Placebo-controlled Study of Oral Fosamax, 70 mg Once a Week, for the Prevention of Androgen Deprivation Bone Loss in Non-metastatic Prostate Cancer
This is a phase three multicentre, double blind, randomize parallel group,
placebo-controlled study in 250 men with histologically proven cancer without bone
metastases who are beginning ADT therapy and who will receive a concomitant treatment with
either oral Fosamax 70 mg once a weak (n=125) or placebo (n=125) for one year. Changes in
BMD, markers of bone absorption and formation are monitored.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Bone mineral density
Lesley Carr, M.D.
Sunnybrook Health Sciences Centre
Canada: Health Canada